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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD MCKESSON BRANDS; SYRINGE LL 5CC
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JIANGSU CAINA MEDICAL CO.,LTD MCKESSON BRANDS; SYRINGE LL 5CC Back to Search Results
Catalog Number 16-S5C
Device Problem Crack (1135)
Patient Problem Exposure to Body Fluids (1745)
Event Date 08/19/2019
Event Type  malfunction  
Event Description
It was reported that the 5cc syringe shattered while performing a platelet rich plasma injection.Patient's blood was drawn with 5cc syringe and 18g needle.Blood was put in centrifuge in a tube and then injected back into patient using the exact same syringe and a 22.5g needle.During the injection the syringe burst exposing the doctor and medical assistant to the patient's blood.
 
Event Description
It was reported that the 5cc syringe shattered while performing a platelet rich plasma injection.Patient's blood was drawn with 5cc syringe and 18g needle.Blood was put in centrifuge in a tube and then injected back into patient using the exact same syringe and a 22.5g needle.During the injection the syringe burst exposing the doctor and medical assistant to the patient's blood.
 
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Brand Name
MCKESSON BRANDS
Type of Device
SYRINGE LL 5CC
Manufacturer (Section D)
JIANGSU CAINA MEDICAL CO.,LTD
no.23 huanxi rd
zhutang town
jiangyin city, 20180 3
CH  201803
MDR Report Key8950108
MDR Text Key156909440
Report Number1451040-2019-00008
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 08/30/2019,09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number16-S5C
Device Lot NumberCJCH12-01
Was Device Available for Evaluation? No
Distributor Facility Aware Date08/21/2019
Device Age8 MO
Date Report to Manufacturer08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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